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Evaluation of Thermal-Aided Muscle Stimulation

N

Niveus Medical

Status

Unknown

Conditions

Weakness
Atrophy

Treatments

Device: Body Temperature Stimulation
Device: Thermal-aided muscle stimulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT01911312
CLP3.00

Details and patient eligibility

About

An investigation into the relative effectiveness of thermal-aided muscle stimulation vs. body temperature muscle stimulation for eliciting muscle contraction in the quadriceps

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subject does not meet any exclusion criteria

Exclusion criteria

  • Age < 18 years
  • Subject is pregnant
  • Subject has an implanted pacemaker/defibrillator
  • Subject diagnosed with epilepsy
  • Subject has implanted metallic femoral rods
  • Subject is chair- or bed-bound
  • Subject has neuromuscular disease or abnormalities
  • Subject BMI > 45
  • Evidence of disease or condition that, in the opinion of the investigator, may compromise the conduct of or results of the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Intervention
Experimental group
Treatment:
Device: Thermal-aided muscle stimulation
Body Temperature Control
Active Comparator group
Description:
Stimulation performed with body temperature control
Treatment:
Device: Body Temperature Stimulation

Trial contacts and locations

1

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Central trial contact

Brian Fahey, PhD

Data sourced from clinicaltrials.gov

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